What To Know
- The endpoints of the trial included an evaluation of the association of biometric data with arrhythmias and symptoms and the demonstrated clinical utility provided by adding biometric data to traditional MCT event and end-of-use reports.
- In the MAPS Trial, physicians reported that in patients who had no reported arrhythmias or symptoms, ZOLL AMS data helped them better understand the patient status compared to traditional ECG-only MCT data.
ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced the launch of the ZOLL Arrhythmia Management System (AMS).
ZOLL AMS adds biometric data (heart rate, activity, respiratory rate, and body posture) to the ECG information provided by traditional MCT devices. A new study demonstrates that ZOLL AMS helps physicians make more informed patient treatment plans.
The MAPS Trial (Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device Trial) is the largest prospective, multicenter MCT study ever conducted, enrolling 583 patients. The endpoints of the trial included an evaluation of the association of biometric data with arrhythmias and symptoms and the demonstrated clinical utility provided by adding biometric data to traditional MCT event and end-of-use reports. The trial met all endpoints and is the first MCT study to document, in a real-world setting, statistically significant relationships between arrhythmias and biometric parameters and between patient symptoms and biometrics.
Physicians first reviewed traditional MCT reports for all events and patients and made treatment plan recommendations. Physicians then reviewed the ZOLL AMS reports for the same events and patients, which included biometric data along with traditional MCT data. The addition of ZOLL AMS biometric data and insights led to treatment plan changes for more than 60% of patients compared to traditional MCT and included adjustments to lifestyle, medications, and follow-up plans. The results demonstrate the significant impact of these data on patient care decisions.
“The patient biometric data available from ZOLL AMS represents a leap forward in MCT technology,” said Robert L. Salazar, M.D., F.A.C.C., Texas Cardiology Associates of Houston, an investigator on the MAPS Trial. “ZOLL AMS data enhance the clinical picture by providing context to arrhythmic or symptomatic events. For example, a patient experiencing bradycardia while exercising would require a vastly different care plan than if they experience bradycardia while napping. With ZOLL AMS, we can get that level of clarity.”
With ZOLL AMS, physicians receive timely event-based reports, as well as comprehensive end-of-use reports with clinically relevant data, including sleep, activity, respiratory rate, and patient status, to help assess a patient’s broader health and wellness and guide meaningful treatment decisions.
“ZOLL AMS is the next generation of MCT with a feature set that significantly advances cardiac patient monitoring,” said Jason T. Whiting, President of ZOLL Cardiac Management Solutions. “ZOLL AMS now provides physicians with meaningful clinical value for all MCT patients, including those who do not experience an arrhythmia or symptoms. In the MAPS Trial, physicians reported that in patients who had no reported arrhythmias or symptoms, ZOLL AMS data helped them better understand the patient status compared to traditional ECG-only MCT data.”
The full results of the MAPS Trial are anticipated to be published in the spring of 2022. To learn more about the MAPS Trial, visit https://clinicaltrials.gov/ct2/show/NCT04754204.
ZOLL AMS is initially available in select U.S. markets followed by expansion throughout the U.S. in the coming months.
